Homocysteine in Critically Ill Preeclampsia

The Clinical Utility of Homocysteine in Critically Ill Preeclampsia Patients

Preeclampsia is a disorder characterized by the new onset of hypertension and proteinuria typically presenting after 20 weeks of gestation. Elevated circulating homocysteine is a risk factor for endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Our study is to investigate the association between elevated blood homocysteine levels and complications in pregnant women in order to conclude the clinical utility of homocysteine as a marker of severity in the cases of pre-eclampsia.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Pre-Eclampsia
• Intervention / Treatment: Diagnostic test: homocysteine measurement

Detailed Description

Hypertensive disorders of pregnancy are an important cause of morbidity and mortality among mothers and infants. Preeclampsia is a pregnancy-related hypertensive disorder occurring usually after 20 weeks of gestation. It is associated with fetal growth restriction, low birth weight, preterm birth, respiratory distress syndrome, and admission to a neonatal intensive care unit. According to a systemic review and meta-analysis published in 2013, preeclampsia has a noticeable relationship with an increased risk of developing hypertension, ischemic heart disease, and cerebrovascular accident in later life.

There is already abundant evidence indicating that elevated serum homocysteine levels may be related to the risk of coronary, cerebral, and peripheral arterial diseases. Elevated circulating homocysteine is a risk factor of endothelial dysfunction and vascular diseases such as atherosclerosis and occlusive disorders. Normally, homocysteine levels decline throughout pregnancy and since the vascular alterations brought on by homocysteine are comparable to those brought on by hypertensive disorders of pregnancy, it can be assumed that high levels of homocysteine are linked to the hypertensive disorder spectrum. Homocysteine has been shown to produce oxidative stress and endothelial dysfunction, endothelial cell injury and thrombus formation and thereby producing pre-eclampsia.

Estimation of homocysteine may help to predict and prevent pre-eclampsia and eclampsia, thus reducing the undesired outcome of pregnancy.

Among various studies, there is a lack of consistency in the reported results that support the link between maternal homocysteine concentrations assessed throughout each of the three trimesters of pregnancy and difficulties caused by the placenta.

our study investigate the relation between the level of homocysteine and severity of preeclampsia.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: wessam selima, MD; Phone Number: +201001958858; Email: w.z.selima@gmail.com
• Study Contact Backup: Name: Amera ahmed, MD; Phone Number: +201000358439

Study Locations

• Egypt
  • Cairo, Egypt, 11591
    • Recruiting
    • Ain Shams University
    • Contact: fathy tash, MD; Phone Number: 7539 2022685; Email: REC-FAMSU@med.asu.edu.eg
    • Principal Investigator: Rania Gamal, MD
    • Principal Investigator: Amera Ahmed, MD
    • Principal Investigator: Rasha Ahmed, MD
  • القاهرة
    • Cairo, القاهرة, Egypt
      • Recruiting
      • Ain Shams University
      • Contact: Anesthesia department; Phone Number: 01009499962; Email: anesth_office@med.asu.edu.eg
      • Contact: Email: w.z.selima@med.asu.edu.eg
      • Principal Investigator: wessam selima, MD
      • Principal Investigator: Rania Gamal, MD
      • Principal Investigator: Amera Ahmed, MD
      • Principal Investigator: Rasha Ahmed, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

pregnant females with pre-eclampsia and within 24 hours of delivery

Description

Inclusion Criteria:

• All patients diagnosed by preeclampsia will be included in light of the following diagnostic criteria (blood pressure more than 140\90 mm\Hg on 2 occasions at least 4 hours apart after 20 weeks' gestation in a previously normotensive patient accompanied by Protein/creatinine ratio ≥0.3 .

Exclusion Criteria:

• Essential hypertension suggested by history or documentation of hypertension in pre pregnant state or hypertension before 20 weeks of gestation.
• Cardiovascular or renal failure
• Liver failure
• Diabetes mellitus
• Inflammatory or infective disorders
• History or documentation of epilepsy in prepregnant state
• Space occupying lesion in brain like tuberculoma or brain tumor
• Trauma to brain
• Hyperpyrexia
• On treatment with antifolate drugs such as methotrexate

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
normal pregnancy; Normotensive age- matched pregnant controls	Diagnostic test: homocysteine measurement; measuring the serum level of homocysteine
preeclampsia; pre-eclampsia patients who are managed in ward (not critical)	Diagnostic test: homocysteine measurement; measuring the serum level of homocysteine
critically ill preeclampsia; pre-eclampsia patients who are admitted to intensive care unit due to severity or complications	Diagnostic test: homocysteine measurement; measuring the serum level of homocysteine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
homocysteine level	Quantitative measurement of the serum level of homocysteine. The measurement will be done using a commercially available sandwich enzyme linked immunosorbent assay (ELIZA) kit supplied by ( Bioassay technology laboratory) according to the manufacturer's instructions.nthe results will be expressed in ng/ml. Absorbance of standards and samples were measured at 450 nm using a microtiter plate ELISA reader .	within 24 hours postoperative(post delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Statistical correlation analysis will be done between homocysteine levels and severity of preeclampsia	the co relation between levels of homocysteine and degree of severity of preeclampsia using spearman rank correlation co efficient	within 24 hours postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University

Publications and helpful links

General Publications

• Salam RA, Das JK, Ali A, Bhaumik S, Lassi ZS. Diagnosis and management of preeclampsia in community settings in low and middle-income countries. J Family Med Prim Care. 2015 Oct-Dec;4(4):501-6. doi: 10.4103/2249-4863.174265.
• Thakur P, Bhalerao A. High Homocysteine Levels During Pregnancy and Its Association With Placenta-Mediated Complications: A Scoping Review. Cureus. 2023 Feb 20;15(2):e35244. doi: 10.7759/cureus.35244. eCollection 2023 Feb.
• Chaudhry SH, Taljaard M, MacFarlane AJ, Gaudet LM, Smith GN, Rodger M, Rennicks White R, Walker MC, Wen SW. The determinants of maternal homocysteine in pregnancy: findings from the Ottawa and Kingston Birth Cohort. Public Health Nutr. 2020 Dec;23(17):3170-3180. doi: 10.1017/S1368980019004002. Epub 2020 Mar 19.
• Aubard Y, Darodes N, Cantaloube M. Hyperhomocysteinemia and pregnancy--review of our present understanding and therapeutic implications. Eur J Obstet Gynecol Reprod Biol. 2000 Dec;93(2):157-65. doi: 10.1016/s0301-2115(00)00282-7.

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): May 19, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: May 12, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): May 14, 2024
• Last Update Submitted That Met QC Criteria: May 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pregnancy Complications; Hypertension, Pregnancy-Induced; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Critical Illness; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: FMASU R09/2024

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No